Pilar Calvo Salve

On June 18th, the new transparency rules for the European clinical trials database 𝗖𝗧𝗜𝗦 (Clinical Trials Information System) came into force. According to the new CTIS standards, some documents will be published along with trial data keys, 𝘀𝗶𝗺𝗽𝗹𝗶𝗳𝘆𝗶𝗻𝗴 𝘁𝗵𝗲 𝗰𝗿𝗲𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗼𝗳 𝗿𝗲𝗾𝘂𝗲𝘀𝘁𝘀. We are experts in 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝘀𝘁𝗮𝗿𝘁-𝘂𝗽. Trust your clinical research projects with APICES CRO.  Check the new regulations here ⬇️ #CRO #ClinicalStudies #ClinicalTrials #puestaenmarcha 🇪🇸 | El 18 de junio entraron en vigor las nuevas normas de transparencia de la base de datos europea de ensayos clínicos (CTIS). Siguiendo las nuevas normas de 𝗖𝗧𝗜𝗦, se harán públicos algunos documentos, que se publicarán junto con datos clave del ensayo. De esta forma, 𝘀𝗲 𝘀𝗶𝗺𝗽𝗹𝗶𝗳𝗶𝗰𝗮 𝗹𝗮 𝗰𝗿𝗲𝗮𝗰𝗶𝗼́𝗻 𝘆 𝗲𝗻𝘃í𝗼 𝗱𝗲 𝘀𝗼𝗹𝗶𝗰𝗶𝘁𝘂𝗱𝗲𝘀. Somos especialistas en 𝗽𝘂𝗲𝘀𝘁𝗮 𝗲𝗻 𝗺𝗮𝗿𝗰𝗵𝗮 𝗱𝗲 𝗲𝗻𝘀𝗮𝘆𝗼𝘀 𝗰𝗹í𝗻𝗶𝗰𝗼𝘀. ¡Confía tus proyectos de investigación clínica a APICES CRO! Consulta la nueva normativa aquí ⬇️ #EnsayosClínicos #EstudiosClínicos #InvestigaciónClínica #CTIS

22

Our colleague Juan Carlos Triviño, PhD, BioInformatic Expert in Sistemas Genómicos | member of SYNLAB, is leading session #3: "Beyond DNA: Regulatory-region analysis and its possible impact on clinical diagnosis", of our symposium: "NEW TECHNOLOGIES AND APPROACHES IN CLINICAL GENOMICS" at ESHG2024. Regulatory-region analysis is not just a tool, but a key to unlocking a comprehensive understanding of genetic diseases. By including these regions in genetic testing, we can significantly enhance diagnostic accuracy, inform personalized treatment strategies, and provide invaluable insights for genetic counselling. As sequencing technologies and bioinformatics tools continue to advance, the ability to detect and interpret regulatory mutations will improve, leading to better clinical outcomes and more precise medical interventions. More info: direcciondeservicios@sistemasgenomicos.com We look forward to seeing you at our booth #570 #ESHG2024 #Genetic #SistemasGenomicos

45

📢 𝗔𝗘𝗠𝗣𝗦 𝘄𝗶𝗹𝗹 𝘀𝘁𝗮𝗿𝘁 𝘄𝗼𝗿𝗸𝗶𝗻𝗴 𝗼𝗻 𝘁𝗵𝗲 𝗧𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰 𝗣𝗼𝘀𝗶𝘁𝗶𝗼𝗻𝗶𝗻𝗴 𝗥𝗲𝗽𝗼𝗿𝘁𝘀 (𝗧𝗣𝗥𝘀) 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 𝘄𝗶𝘁𝗵 𝗮 𝗽𝗼𝘀𝗶𝘁𝗶𝘃𝗲 𝗖𝗛𝗠𝗣 𝗼𝗽𝗶𝗻𝗶𝗼𝗻 𝗮𝘁 𝘁𝗵𝗲 𝗠𝗮𝗿𝗰𝗵 𝟮𝟬𝟮𝟰 𝗺𝗲𝗲𝘁𝗶𝗻𝗴. 𝗡𝗲𝘄 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀:  - 𝗔𝘄𝗶𝗾𝗹𝗶 (insulin icodec): from Novo Nordisk A/S, indicated for the treatment of diabetes mellitus in adults. - 𝗘𝗺𝗯𝗹𝗮𝘃𝗲𝗼 (aztreonam / avibactam): from Pfizer Europe Ma EEIG, indicated for the treatment of the following infections in adult patients: o Complicated intra-abdominal infection (IIAc). o Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP). o Complicated urinary tract infection (cUTI), including pyelonephritis. Emblaveo is also indicated for the treatment of infections caused by aerobic gram-negative microorganisms in adult patients with limited therapeutic options. - 𝗙𝗮𝗯𝗵𝗮𝗹𝘁𝗮 (iptacopan): from Novartis Europharm Limited, indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) presenting with haemolytic anaemia. - 𝗟𝘆𝘁𝗲𝗻𝗮𝘃𝗮 (bevacizumab gamma): from Outlook Therapeutics Limited, indicated for the treatment of neovascular (wet) age-related macular degeneration in adult patients. And also, 𝗻𝗲𝘄 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗕𝗶𝗺𝘇𝗲𝗹𝘅 (bimekizumab), 𝗡𝗶𝗹𝗲𝗺𝗱𝗼 (bempedoic acid), 𝗡𝘂𝘀𝘁𝗲𝗻𝗱𝗶 (bempedoic acid/ezetimibe), 𝗢𝗻𝗶𝘃𝘆𝗱𝗲 𝗽𝗲𝗴𝘆𝗹𝗮𝘁𝗲𝗱 𝗹𝗶𝗽𝗼𝘀𝗼𝗺𝗮𝗹 (irinotecan free anhydrous base), 𝗥𝗲𝘁𝘀𝗲𝘃𝗺𝗼 (selpercatinib) and 𝗫𝘁𝗮𝗻𝗱𝗶 (enzalutamide). Link: https://lnkd.in/d-77a3fx #Pharmaceuticals #TPR #AEMPS #MarketAccess #Spain

14

When we talk about innovation, we talk about Nemera. We represent NEMERA in Spain and Portugal, offering injectable PENs as PENVARIO (for diabetes) and ophthalmics as NOVELIA. See the video below for some characteristics of the innovation process led by Nemera. https://lnkd.in/dBAKS5AK

6

When patient drop-out continues to be a challenge in today's clinical trials, obtaining a 95% patient retention rate is such a huge success! We want to celebrate it by sharing with you how Almirall obtained 95% patient retention in the AKtive study, a Phase IV, three-year study in which patients were required to report outcomes periodically and avoid sunlight or UV light exposure. Read the case study by clicking here: https://lnkd.in/edUvVrFJ

4

🔬 Excited to share our feature in PMFarma Magazine about "Innovación y Retos del sector de Diagnóstico In Vitro en España"! Discover the challenges and innovation within Spain's in vitro diagnostics sector. In vitro diagnostic medical devices (IVDs) are critical, influencing 70% of clinical decisions in Europe, yet they represent only 1% of public health expenditure. 💉 Learn from our NAMSA experts, Ariadna Navarro Aragall, PhD and Beatriz Rodriguez Grande, as they delve into the IVD sector's state, economic significance, and obstacles during regulatory shifts and innovation pursuits. 💡 Catch this enlightening piece on Spain's approach to the complex IVD market, driving research, development, and leading in the MedTech field. 🚀 Read the full article in PMFarma Magazine, May-June 2024 edition. https://lnkd.in/dRDC_4BE 📍 The article is in Spanish, but you can find the English version in the online edition. #IVD #Innovation #Healthcare #MedTech #PMFarmaMagazine

7

1 comentario

🔬 On #InternationalDayofImmunology, we celebrate the vital role of immunology in health and disease. At #ENDOMIX, we are dedicated to understanding how EDCs impact the immune system, contributing to a healthier future for all 🙌 🌎 If you want to know more about our project and objectives, visit us on: 🔗 https://endomix.eu/ #DayofImmunology

13

#Antibodies for Immunohistochemistry: an analysis of validated references from the Absolute Biotech group. Distributed in Spain and Portugal by Abyntek Biopharma, the Absolute Biotech is a prominent reference in the manufacturing of #bioreagents for research, consisting of the merger of six innovative companies: LSBio, Exalpha, Absolute Antibody, Everest, Nordicmubio, and Kerafast. Each of these companies brings its expertise and specialized knowledge to offer a wide range of antibodies and #reagents that meet the highest standards of quality and specificity. In this article, we will explore the various options of reagents offered by the Absolute Biotech group, emphasizing high-quality antibodies for #immunohistochemistry. 👉 Discover it and get a 30% discount on the second until April 30, 2024: https://lnkd.in/dHNc69Aj #Biotech https://lnkd.in/dnQKe3cT

5

https://lnkd.in/dv3FUD4g   Article title: Unveiling the connections: Chlorpyrifos and its association with breast cancer   Author(S): Eliana Estrella Akselrad, María de la Cabeza Fernández*, Paula Moyano and María Victoria Naval*   Journal: Journal of Clinical Microbiology and Biochemical Technology   Journal ISSN: 2581-527X Abstract: Chlorpyrifos, a broad-spectrum insecticide categorized within the organophosphate family, is recognized for its potent inhibition of the enzyme Acetylcholinesterase (AChE), resulting in the manifestation of cholinergic syndrome in humans. Beyond its well-established toxicity in the central nervous system, recent studies have explored additional pathways through which this pesticide may adversely impact human health. Breast cancer, characterized by the uncontrolled proliferation of epithelial cells in the mammary gland, stands as the most diagnosed cancer in women and is a leading global cause of female cancer-related deaths. Chlorpyrifos, extensively employed worldwide for pest control in agriculture, domestic settings, and industries, has notably faced recent bans in the European Union, marking a significant regulatory shift. This bibliographical review aims to unravel the intricate mechanisms by which chlorpyrifos may contribute to the development of breast cancer. #Chlorpyrifos #Breastcancer #Organophosphate #Endocrinedisruptor   #CellularMicrobiology #EnvironmentalMicrobiology #MedicalMicrobiology #IndustrialMicrobiology #MarineMicrobiology #AquacultureMicrobiology #Bacteriology #Chlamydiology #Rickettsiology #Peertechz #PeertechzPublications #Mycobacteriology #AerobicActinomycetes #Mycology #Parasitology #Virology #ClinicalVeterinaryMicrobiology #Epidemiology #Biochemical #Endocytosis #Exocytosis #MembraneBiology #CellMigration #CellMatrix #OrganelleBiogenesis #Cytoskeleton #Proteolysis #CellDeath #CellCycle #CancerResearch #CellGrowth #CellDeath #CellDifferentiation #DrugTargets #GeneTherapy #DiseaseModels #Proteomics #StemCells #Bioenergetics #Mitochondria #FreeRadicals #RedoxSignaling #IonTransport #OxidativeStress #CellularMetabolism #XenobioticMetabolism #Metabolomics #CircadianControls #Hormones #Photosynthesis #CellSignaling #NitrogenFixation #PlantDisease #TransportProcesses #PlastidSystems #CellWallSynthesis #Phosphorylation #ProteinKinases #Phosphates #Ubiquitination #LipidSignaling #SecondMessengers #Cytokines #Receptors #GrowthFactors #GProteins #Integrins #NitricOxide #Enzymology #MolecularMechanisms #Biophysics #BiomolecularAssociations #SystemsBiology #ChemicalBiology #ProteinStructure #NucleicAcids #AminoAcids #DrugDesign #BiomolecularTargets #Lipids #Carbohydrates #EnvironmentalBiotechnology #MetabolicEngineering #TissueEngineering #Biodiversity #AgroBiotechnology #MedicalBiotechnology

1

Lung cancer remains one of the most challenging cancers, and early detection is crucial for effective treatment.   🤍 As a contribution to #WorldLungCancerDay, and because each study brings us one step closer to better #patientcare, we wanted to share our latest research, led by Almudena Fuster Matanzo and Alfonso Picó.   📋 This comprehensive meta-analysis explores the potential of artificial intelligence in classifying tumor genetic profiles through CT scans. Our review encompasses 89 models, analyzing data from 32,084 non-small cell lung cancer (NSCLC) patients. The findings demonstrate promising correlations between imaging and genetic features.   🔗 Read the full study: https://lnkd.in/ei66kFNe   #LungCancer #CancerResearch 

38

2 comentarios

So excited to be part of this project... 😃 AEFI - Asociación Española de Farmacéuticos de la Industria has become a member of the #CriticalMedicinesAlliance of the #EuropeanCommission. Today, we have attended the #inaugural meeting, where the objectives of the Alliance, the challenges and the paths forward have been discussed. The Critical Medicines Alliance (CMA), set up in January 2024, is a consultative mechanism bringing together relevant stakeholders from #EU Member States, key industries, the civil society, and the scientific community. The Alliance aims to identify key areas and priorities for action, proposing solutions to strengthen the #supply of critical medicines in the EU, ultimately enhancing efforts to prevent and address #shortages effectively. From AEFI we are so proud to be part of this Alliance, and will work hard to contribute and to add value, on the interest of our members and of the whole healthcare industry in Spain. #biopharma #compliance #regulation #quality #supplychain #patients #future

19

Join Josep M Piulats, MD, PhD, and leading experts as they explore the importance of precision in developing effective immuno-oncology tools and treatments. Learn about current technologies, exploring the latest tools in patient monitoring; T cells as biomarkers, understanding the potential of T cells in tracking immunotherapy success; and importance of precision, explaining why precise tools are critical to inform and develop effective cancer treatments. Don't miss out. 📺 Watch full discussion here: https://lnkd.in/d9ysQh-r #ScienceIsWeAll #PrecisionOncology

11

1 comentario

🇲🇽 Article available in https://lnkd.in/eTVEqvyK #Conahcyt, #chia, #compuestosbioactivos, #Alimentosfuncionales, #salud, #BioactiveCompounds, #functionalfood, #health, #ciencia, #investigacióndefrontera, #CancerPrevention, #alimentacionsaludable

5

🎂 CiBB GreenLabs celebrates 2 years 🎂 Today marks the 2nd anniversary of the GreenLabs initiative of the Center for Innovation in Biomedicine and Biotechnology (CiBB), an R&D unit that includes Center for Neuroscience and Cell Biology, iCBR - Coimbra Institute for Clinical and Biomedical Research, MIA Portugal and GeneT. The Green Lab initiative promotes the implementation of daily sustainable practices in research laboratories to reduce the carbon and energy footprint and mitigate the environmental impact of research, with the clear aim of protecting the environment.  These practices are carried out while maintaining research quality and excellence and within health and safety standards. Since 2022, the daily waste associated with research has already been reduced, by encouraging practices of reducing, reusing and recycling materials, the practice of more environmentally friendly purchases (products/equipment), the conscious printing of documents, the practice of sustainable travel and the holding of eco-conscious events.  ♻ Universidade de Coimbra Image credit: Rita Félix

9

📢 𝗢𝗺𝗮𝗸𝗮𝘀𝗲 𝗺𝗼𝗱𝗲𝗿𝗮𝘁𝗲𝘀 𝗸𝗲𝘆 𝗵𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗱𝗲𝗯𝗮𝘁𝗲 𝗼𝗻 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝘁𝗵𝗲𝗿𝗮𝗽𝘆 𝗮𝗰𝗰𝗲𝘀𝘀 𝗮𝗻𝗱 𝗿𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗺𝗲𝗻𝘁 𝗶𝗻 𝗦𝗽𝗮𝗶𝗻.⁣  ⁣ Omakase was thrilled to have participated moderating this great initiative under the sponsorship of Pierre Fabre and coordinated by Wecare-U on the necessary debate and ongoing work by c𝗲𝗻𝘁𝗿𝗮𝗹 𝗮𝗻𝗱 𝗿𝗲𝗴𝗶𝗼𝗻𝗮𝗹 𝗵𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝘀𝘆𝘀𝘁𝗲𝗺 𝘀𝘁𝗮𝗸𝗲𝗵𝗼𝗹𝗱𝗲𝗿𝘀 in Spain on 𝗸𝗲𝘆 𝗮𝘀𝗽𝗲𝗰𝘁𝘀 𝗿𝗲𝗴𝗮𝗿𝗱𝗶𝗻𝗴 𝗿𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗮𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝘁𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀, including advanced therapies in Spain. ⁣ ⁣ Derived from the transposition of the EU Pharmaceutical legislation, we shall see many and impactful 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗶𝗻 𝗹𝗲𝗴𝗶𝘀𝗹𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗶𝗻 𝗦𝗽𝗮𝗶𝗻 𝗶𝗻 𝘁𝗵𝗲 𝗳𝗼𝗿𝘁𝗵𝗰𝗼𝗺𝗶𝗻𝗴 𝗺𝗼𝗻𝘁𝗵𝘀, with the common objective to seek new formulas to incorporate 𝗱𝗶𝘀𝗿𝘂𝗽𝘁𝗶𝘃𝗲 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 in a timely and adequate manner and obtain sought outcomes while ensuring the sustainability of the Spanish NHS system. Great efforts and advances have been and are being made.⁣  ⁣ The common will and vision are there.⁣  ⁣ 🔎Further information:⁣ https://lnkd.in/dKAkp-Es https://lnkd.in/d83JF4hq https://lnkd.in/dXskZbPb #Reimbursement #Access #Innovativetherapies #Advancedtherapies #Spain

19

Clinical Trials in Spain Accelerated: AEMPS - Agencia Española de Medicamentos y Productos Sanitarios Launches Fast-Track Evaluation Procedure The Spanish Agency of Medicines and Medical Devices (AEMPS - Agencia Española de Medicamentos y Productos Sanitarios) has launched a fast-track evaluation procedure for clinical trials, aiming to enhance Spain's appeal for innovative medical research and development. This new process, in line with the European Union Regulation 536/2014, promises to significantly reduce the timeframes for evaluating and authorizing clinical trials that meet specific criteria. This includes Phase I trials involving advanced therapy medicinal products (ATMPs) and targeting severe, life-threatening diseases without existing therapies. The procedure requires exclusive submission through the European Union's Clinical Trial Information System (CTIS) and adherence to fast-track requirements by selected Ethics Committees (CEIm). For more details please click the link! https://lnkd.in/dseyWtQA #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

3

BHH member Goo Apps collaborated with the Hospital Universitario Ramón y Cajal and the Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS to develop #QuickVaccine. Adult vaccination rates in Spain are worryingly low, with only 30% vaccinated against pneumococcus and less than 50% against seasonal flu. This situation poses a serious challenge to public health, increasing the incidence of preventable diseases and #healthcare costs. GooApps' article describes the creation process of QuickVaccine, from identifying the need to improve adult vaccination to implementing advanced technological solutions. Read it here: https://lnkd.in/da7meWGk

6

1 comentario